Addressing Pharmaceutical Injuries: The US Landscape
There are a number of benefits to the no‐fault government‐run compensation system used in Japan and described in this manuscript—its speed, efficiency, contributions to the regulatory safety landscape, and the fact that the injured party is required to expend minimal effort and no money in seeking compensation. Although use of the Japan Relief System is not mandatory and an individual may bypass the system and initiate civil litigation against the pharmaceutical manufacturer, the cost of pursuing litigation and the difficulty of recovering under Japanese law prompt most patients to use the Relief System as the sole mechanism for seeking relief. As a result, whereas Japan‐based pharmaceutical companies incur certain costs to fund the Relief System, they generally do not incur significant additional costs to evaluate and defend against pharmaceutical injury civil litigation claims.
The landscape for addressing pharmaceutical injuries in the United States is drastically different and significantly more complex. With the exception of a special system set up for certain vaccine‐related injuries (discussed further below), there is no widespread no‐fault compensation scheme in place, nor does the US Food and Drug Administration (FDA) or any other federal agency play a direct role in assessing the merits of pharmaceutical injury claims. Instead, the vast majority of pharmaceutical injury claims are brought through the civil litigation system at the state level, with claims based on various state laws and theories pertaining to the duties of manufacturers. Theories include manufacturing or design defect, or “failure to warn”—the latter theory based on the premise that a manufacturer must provide proper warnings about the dangers and risks of its product so that a consumer can make an informed decision about whether and how to use it. In failure to warn pharmaceutical cases, plaintiffs allege that their injury was caused by the pharmaceutical product, that the manufacturer knew or had reason to know about the risk, and that the product labeling did not adequately warn them of the potential risk. The burden then shifts to the manufacturer to demonstrate either that the injury suffered was not related to the product, or that the product labeling provided adequate warnings such that the claimant was on notice about the potential risk. The legal dispute, therefore, focuses heavily on the labeling of the product, as well as the facts regarding what a manufacturer knew about the safety profile of its product, and whether the company updated the labeling in a timely and comprehensive manner.
Of course, a critical part of the FDA's mission is its review of product labeling.